Identity
- Trade Name
- FloSwitch™ EUDAMEDFloSwitch™ HP FDA UDI
- Generic Name
- Stopcock FDA UDI
- Device Name
- FloSwitch HP EUDAMEDHigh Pressure Flow Control Device FDA UDI
- Model / Reference
- M001442010 EUDAMEDFDA UDI
- Description
- High Pressure Flow Control Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729739319 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000331MS EUDAMED
- FDA Product Code
- DQO FDA UDI
- EMDN Code
- C01040280 PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Stopcock FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Vascular catheter introduction set, nonimplantable
FloSwitch™ by Boston Scientific Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000331MS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 84535333-c3a4-478f-b58b-4767ba17efa0 61 fields · synced Jun 18, 2026
- FDA UDI bc5e60a2-9dfb-46d5-b87e-645f1c807341 33 fields · synced May 30, 2026